Perforated AppendicitisNCT00462020
Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
A study testing 5 days of IV antibiotics (ceftriaxone and metronidazole) and Home with oral antibiotics when eating (ampicillin/clavulanic acid) in people with Perforated Appendicitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis. The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- 5 days of IV antibiotics (ceftriaxone and metronidazole) and Home with oral antibiotics when eating (ampicillin/clavulanic acid)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Identifiable hole in the appendix or stool in the abdomen at the time of appendectomy
Who cannot join
- Known immune deficiency
- Abscess identified on pre-op imaging
- Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis.
The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient.
The primary outcome variable between the two strategies is abscess rate.
Read the detailed description
This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study.
Power calculation was based on abscess rate in the previous prospective, randomized study we just finished. Our current rate is 18%, or just under one-fifth of the patients. A doubling of this rate to 36% would place just over one third of the patients at risk which would be unacceptable. Using a delta of 0.18 with alpha of 0.05 and power of 0.8, the sample size is 74 patients in each arm. Therefore we will anticipate enrolling 150.
Subjects will be those children who undergo a laparoscopic appendectomy as part of their routine care.
Perforation will be defined as an identifiable hole in the appendix or stool in the abdomen.
The control group will receive current standard care: ceftriaxone 50mg/kg once a day (maximum dose = 2 grams) and metronidazole 30mg/kg once a day (maximum dose = 1 gram) with once a day dosing for both. The length of antibiotic therapy will be a minimum of 5 days. At that time, if they have been afebrile for at least 24 hours, a white blood cell (WBC) count will be obtained, and if that is within normal limits, the antibiotics will be discontinued and the patient will be discharged. If the WBC is elevated, they will receive another 2 days before recheck, if still elevated, they receive another 3 days and a CT Scan is obtained. If, after 5 days of therapy, the patient remains febrile, therapy will continue until afebrile before a WBC check is performed. This is all our current standard management.
The experimental group will receive the same combination of antibiotics while in the hospital. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. The home antibiotic regimen will be ampicillin/clavulanic acid (Augmentin®). Augmentin® dose will be 40mg/kg twice a day. They will be asked to bring their pill containers with them to clinic where we will quantify medication compliance.
Given the purpose of this study is the comparison of oral antibiotics to intravenous antibiotics, an allergy to one of the above medications will not be considered an exclusion criteria. In such cases the patient will be treated with an alternative that offers the same spectrum of coverage, but will be included in the study.
- Conditions
- Perforated Appendicitis
- Being tested
- 5 days of IV antibiotics (ceftriaxone and metronidazole), Home with oral antibiotics when eating (ampicillin/clavulanic acid)
- Keywords
- appendicitis, perforation, abscess, treatment
- Medical subject headings
- Appendicitis, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 days of IV antibiotics (ceftriaxone and metronidazole)Drug
5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing)
Home with oral antibiotics when eating (ampicillin/clavulanic acid)Drug
Augmentin 40mg/kg BID when tolerating POs to complete 7 days total
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 5 days of IV antibiotics after appendectomy Receives: Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole) |
| 2 | Experimental | home on oral antibiotics to complete 7 days of treatment when tolerating PO's Receives: Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abscess After Appendectomy
Measured: 1 month
Secondary outcomes (4)
Operative Time
Measured: 1 month
Time to Regular Diet
Measured: 1 month
Length of Stay After Operation
Measured: 1 month
Total Healthcare Visits
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawn D St. Peter, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462020
- Sponsor's protocol ID
- 07 02 031
- Status last verified
- Feb 2021
- First submitted
- 16 Apr 2007
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis
- ClinicalTrials.gov ID
- NCT00462020
- Acronym / sponsor ID
- 07 02 031
- Conditions
- Perforated Appendicitis
- Keywords
- appendicitis, perforation, abscess, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Posted 13 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis.
The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient.
The primary outcome variable between the two strategies is abscess rate.
Detailed description
This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study.
Power calculation was based on abscess rate in the previous prospective, randomized study we just finished. Our current rate is 18%, or just under one-fifth of the patients. A doubling of this rate to 36% would place just over one third of the patients at risk which would be unacceptable. Using a delta of 0.18 with alpha of 0.05 and power of 0.8, the sample size is 74 patients in each arm. Therefore we will anticipate enrolling 150.
Subjects will be those children who undergo a laparoscopic appendectomy as part of their routine care.
Perforation will be defined as an identifiable hole in the appendix or stool in the abdomen.
The control group will receive current standard care: ceftriaxone 50mg/kg once a day (maximum dose = 2 grams) and metronidazole 30mg/kg once a day (maximum dose = 1 gram) with once a day dosing for both. The length of antibiotic therapy will be a minimum of 5 days. At that time, if they have been afebrile for at least 24 hours, a white blood cell (WBC) count will be obtained, and if that is within normal limits, the antibiotics will be discontinued and the patient will be discharged. If the WBC is elevated, they will receive another 2 days before recheck, if still elevated, they receive another 3 days and a CT Scan is obtained. If, after 5 days of therapy, the patient remains febrile, therapy will continue until afebrile before a WBC check is performed. This is all our current standard management.
The experimental group will receive the same combination of antibiotics while in the hospital. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. The home antibiotic regimen will be ampicillin/clavulanic acid (Augmentin®). Augmentin® dose will be 40mg/kg twice a day. They will be asked to bring their pill containers with them to clinic where we will quantify medication compliance.
Given the purpose of this study is the comparison of oral antibiotics to intravenous antibiotics, an allergy to one of the above medications will not be considered an exclusion criteria. In such cases the patient will be treated with an alternative that offers the same spectrum of coverage, but will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 5 days of IV antibiotics (ceftriaxone and metronidazole)5 days of IV antibiotics after appendectomy |
| 2 | Experimental | Drug: Home with oral antibiotics when eating (ampicillin/clavulanic acid)home on oral antibiotics to complete 7 days of treatment when tolerating PO's |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Identifiable hole in the appendix or stool in the abdomen at the time of appendectomy
Key exclusion criteria (3 listed)
- Known immune deficiency
- Abscess identified on pre-op imaging
- Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 days of IV antibiotics (ceftriaxone and metronidazole)5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing) | Drug | 1 |
| Home with oral antibiotics when eating (ampicillin/clavulanic acid)Augmentin 40mg/kg BID when tolerating POs to complete 7 days total | Drug | 2 |
Primary outcome
Abscess After Appendectomy
Time frame: 1 month
4 secondary outcomes
Operative Time
Time frame: 1 month
Time to Regular Diet
Time frame: 1 month
Length of Stay After Operation
Time frame: 1 month
Total Healthcare Visits
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Perforated Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Not yet recruitingPhase 3
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
Appendicitis Perforated, Appendectomy, Laparoscopic
Not yet recruiting
Perforated Appendicitis and Postoperative Antibiotics Pilot Trial
Perforated Appendicitis
Active, not recruiting
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
Appendicitis With Perforation, Appendectomy
Active, not recruitingPhase 2
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
Perforated Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn D St. Peter principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 days of IV antibiotics (ceftriaxone and metronidazole) and Home with oral antibiotics when eating (ampicillin/clavulanic acid) in people with Perforated Appendicitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abscess After Appendectomy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.